Device Pipeline
| Company | Prototype | Safety/ Efficacy Trial(s) | 501(k) / PMA Application | FDA Approval | Product on Market | Condition on Market |
|---|---|---|---|---|---|---|
| Abbott Medical Optics (IntraLase) | 2002 | IntrLase FS Laser | LASIK eye surgery | |||
| Great Batch | Probes | Neuromodulation | ||||
| Histosonics | VortxRx® | Benign Prostate Hyperplasia | ||||
| Imbio | 2014 | Lung Density Analysis | COPD Analysis | |||
| Invia | 2001 | 4D MSPECT | Processing and diagnostic display of reconstructed cardiac emission | |||
| Medtronic (Ablation Frontiers) | Pulmonary Vein Ablation Catheter (PVAC); Multi-channel Radiofrequency Generator GENius | Paroxysmal Atrial Fibrilation (PAF) | ||||
| Securus Medical | Esophageal Temperature Mapping | Cardiac and Tumor Tissue Ablation | ||||
| Tissue Regeneration System (TRS) | 2013 | Cranial Bone Filler | Skeletal Reconstruction / Bone Regeneration Technology |